Successfully Implementing Lean Manufacturing For Late Phase And Commercial CGT

By Bryan Rizzo, Senior Vice President, Head Of Quality

ElevateBio shares its strategic approach to optimizing cell and gene therapy (CGT) manufacturing. As demand and production frequency grow, the company emphasizes the critical timing of lean system investments and the importance of scalable deployment strategies. Their BaseCamp biomanufacturing centers offer end-to-end capabilities, supporting a wide range of modalities including CAR-T, mRNA therapeutics, and gene-edited HSCs.

A key focus is the transition from paper-based to electronic batch records (eBR), tailored to partner needs and product stages. While early-phase partners benefit from hybrid systems for agility, late-phase and commercial partners adopt fully electronic records to improve traceability, reduce deviations, and accelerate release timelines. ElevateBio highlights lessons learned from implementation challenges, such as validation delays and software errors, advocating for robust systems and minimal customization.

The presentation also explores broader digital investments like LIMS integration, environmental monitoring, and data analytics tools. Deployment strategies stress the human element—promoting ownership, gathering user feedback, and aligning investments with product goals. Ultimately, ElevateBio argues that lean principles, when thoughtfully applied, lead to more predictable, efficient manufacturing processes and greater patient impact.